[Federal Register Volume 78, Number 19 (Tuesday, January 29, 2013)]
[Notices]
[Pages 6119-6120]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2013-01851]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health


Submission for OMB Review; Comment Request: National Institutes 
of Health Information Collection Forms To Support Genomic Data Sharing 
for Research Purposes

AGENCY: PHS, DHHS, National Institutes of Health (NIH).

ACTION: Request for comments

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SUMMARY: Under the provisions of Section 3507(a)(1)(D) of the Paperwork 
Reduction Act of 1995, the National Institutes of Health (NIH) has 
submitted to the Office of Management and Budget (OMB) a request to 
review and approve the information collection listed below. This 
proposed information collection was previously published in the Federal 
Register on October 5, 2012 (77 FR 61008), and allowed 60 days for 
public comment. No public comments were received. The purpose of this 
notice is to allow an additional 30 days for public comment. NIH may 
not conduct or sponsor, and the respondent is not required to respond 
to, an information collection that has been extended, revised, or 
implemented on or after October 1, 1995, unless it displays a currently 
valid OMB control number.
    Proposed Collection: Title: National Institutes of Health 
Information Collection Forms to Support Genomic Data Sharing for 
Research Purposes; Type of Information Collection Request: New; Need 
and Use of Information Collection: The NIH mission is to seek 
fundamental knowledge about the nature and behavior of living systems 
and the application of that knowledge to enhance health, lengthen life, 
and reduce the burdens of illness and disability. The sharing of 
research data supports this mission and is essential to facilitate the 
translation of research results into knowledge, products, practices, 
and procedures that improve human health.
    By enabling secondary research questions to be addressed, data 
sharing maximizes the public benefit achieved through research 
investments. NIH's Policy for Sharing of Data Obtained in NIH Supported 
or Conducted Genome-Wide Association Studies (GWAS) was established to 
enable the full value of GWAS data to be realized. GWAS data are 
maintained in a central data repository, the database of Genotypes and 
Phenotypes (dbGaP), which is administered by the National Center for 
Biotechnology Information (NCBI), part of the National Library of 
Medicine at NIH.
    As stipulated in the NIH GWAS Policy, all principal investigators 
(PIs) who receive NIH funding to conduct genomic research are expected 
to register studies with genomic data in dbGaP. The nature of the 
genomic, phenotypic, and other associated data generated through large-
scale human genomic studies requires responsible stewardship throughout 
research and data sharing activities. Since the data being collected 
and shared are from human research participants, the protection of 
participant interests is paramount. PIs submitting data to dbGaP must 
describe any limitations on sharing the data, as defined in the 
informed consent provided by the participants from whom the data were 
originally collected. PIs must also provide basic study information 
such as the type of data that will be submitted to dbGaP and a 
description of the study.
    Researchers interested in using dbGaP data for secondary research 
must submit a request through dbGaP and be granted permission from the 
relevant NIH Data Access Committees to access the data. As part of the 
request process, researchers must provide information such as a 
description of the proposed research use of the dbGaP datasets, a data 
security plan, and a Data Use Certification, in which the researcher 
agrees to the terms and conditions for use of the data. NIH has 
developed online forms, which will be available through dbGaP, in an 
effort to reduce the burden for researchers to complete the study 
registration, data submission, and data access processes.
    Frequency of Response: As necessary.
    Description of Respondents: PIs and senior officials from their 
institutions.
    Estimate of Burden: The burden associated with this information 
collection is calculated in two parts: (1) the burden associated with 
registering genomic studies and submitting data to dbGaP and (2) the 
burden associated with applying for genomic data in dbGaP. The annual 
reporting burden for study registration and data submission is as 
follows: Estimated Number of Respondents: 100; Estimated Number of 
Responses per Respondent: 1; and Estimated Total Annual Burden Hours 
Requested: 63. The annual cost to respondents is estimated at $2,506. 
The annual reporting burden for applying for genomic data in dbGaP is 
as follows: Estimated Number of Respondents: 1, 266; Estimated Number 
of Responses per Respondent: 2; and Estimated Total Annual Burden Hours 
Requested: 1,583. The annual cost to respondents is estimated at 
$63,452. There are no capital, operating, or maintenance costs to the 
respondents.

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                                                                Estimated
                                              Estimated         number of      Average burden    Estimated total
           Type of respondent                 number of       responses per   per response (in    annual burden
                                             respondents       respondent          hours)             hours
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Study Registration and Data Submission:
    PI..................................                50                 1             45/60                38
Senior Official.........................                50                 1             30/60                25
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        Total...........................               100  ................  ................                63
Data Access Request:
    PI..................................               633                 2             45/60               950
Senior Official.........................               633                 2             30/60               633
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        Total...........................             1,266  ................  ................             1,583
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[[Page 6120]]

    Request For Comments: Written comments and/or suggestions from the 
public and affected agencies should address one or more of the 
following points: (1) Evaluate whether the proposed collection of 
information is necessary for the proper performance of the function of 
the agency, including whether the information will have practical 
utility; (2) Evaluate the accuracy of the agency's estimate of the 
burden of the proposed collection of information, including the 
validity of the methodology and assumptions used; (3) Enhance the 
quality, utility, and clarity of the information to be collected; and 
(4) Minimize the burden of the collection of information on those who 
are to respond, including the use of appropriate automated, electronic, 
mechanical, or other technological collection techniques or other forms 
of information technology.
    Direct Comments to OMB: Written comments and/or suggestions 
regarding the item(s) contained in this notice, especially regarding 
the estimated public burden and associated response time, should be 
directed to the: Office of Management and Budget, Office of Regulatory 
Affairs, [email protected] or by fax to 202-395-6974, 
Attention: Desk Officer for NIH. To request more information on the 
proposed project or to obtain a copy of the data collection plans and 
instrument, contact: Sarah Carr, Acting Director, Office of Clinical 
Research and Bioethics Policy, Office of Science Policy, NIH, 6705 
Rockledge Drive, Suite 750, Bethesda, MD 20892; telephone 301-496-9838; 
fax 301-496-9839; or email [email protected], Attention: Ms. Carr.
    Comment Due Date: Comments regarding this information collection 
are best assured of having their full effect if received within 30 days 
of the date of this publication.

    Dated: January 18, 2013.
Sarah Carr,
Acting Director, Office of Clinical Research and Bioethics Policy, 
Office of Science Policy, National Institutes of Health.
[FR Doc. 2013-01851 Filed 1-28-13; 8:45 am]
BILLING CODE 4140-01-P